CEH-EUS for Differentiating GISTs and Leiomyomas: A Multicenter Prospective Self-Controlled Study

NCT07106411 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 288

Last updated 2025-08-06

No results posted yet for this study

Summary

The investigators conduct a prospective, multicenter diagnostic trial primarily aimed at evaluating the value of contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) in differentiating gastrointestinal stromal tumors (GISTs) from leiomyomas, as well as its predictive utility in the risk stratification of GISTs.

Conditions

  • Submucosal Tumor
  • Gastrointestinal Stromal Tumor (GIST)
  • Leiomyoma

Interventions

DIAGNOSTIC_TEST

Endoscopic Ultrasound

Conventional EUS will be performed to evaluate lesion size, echogenicity, border, and layer of origin for differentiation between GISTs and leiomyomas and risk stratification of GISTs.

DIAGNOSTIC_TEST

Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)

CEH-EUS will be conducted using a contrast agent to assess vascularity and enhancement patterns of the lesion for differentiation between GISTs and leiomyomas and risk stratification of GISTs.

Sponsors & Collaborators

  • Zhongnan Hospital

    collaborator OTHER
  • Wuhan Central Hospital

    collaborator OTHER
  • Huazhong University of Science and Technology

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-06-30
Completion
2026-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106411 on ClinicalTrials.gov